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Common challenge to patient participation in clinical trials

Enrolling and retaining patients in a clinical trial is a challenge. Here we discuss the challenge to patient recruitment and how a site management organization can help you with better patient participation for your clinical research.

Common challenge to patient participation in clinical trials

Ever wondered why enrolling and retaining patients in a clinical trial is a challenge? What are the barriers to patient recruitment? How can a site management organization help you in better patient participation for your clinical research?

Barrier #1: Fear of the unknown

To a participant, the entire clinical trial process is full of unknown factors. Many participants believe that they would be better off taking the “standard treatment” rather than something that is new and unknown. Participants often fear that they may be treated as “guinea pigs” and may lose their autonomy. They sometimes have concerns about their odds of receiving a placebo rather than the active drug. Sometimes, they are anxious about unknown side effects.
In order to provide the best experience possible to the participants and to encourage patient recruitment, it is important to address their concerns early during the interactions with the participants. Communicate the steps of the trial and the importance of each process. Talk to them about the benefits of participation. Tell them they will have access to expert health care services. Get them actively involved in their own health care.

Barrier #2: Distrust in either the care provider or the care provided

When there is something unknown to the participants, they tend to harbour misconceptions about it. With the misconceptions, they may develop distrust in either the care provider or the care provided. This is particularly true when dealing with people who are less educated or have poor annual income. Racial and ethnic minorities are often underrepresented in clinical trials.
Being transparent with the participant about each of the processes involved helps participants to gain trust on the care they receive. For this, it is important to break communication barriers such as language, literacy etc. Be sure to use the language that the participant is most comfortable with. This is especially important in a diverse country such as India where not every participant may understand English, the global language of communication or Hindi, the Indian national language. Keep your sentences simple so that there are no barriers to technical communication. A personal touch from the clinical research coordinators (CRCs) goes a long way in removing any distrust that the participants may have.

Barrier #3: Logistical difficulties

Trial participants may have a busy life and the logistical difficulties of participating in a clinical trial may prevent them from being involved in clinical research. They find it difficult to take the day off from work to be able to visit the site on scheduled dates. Transportation to and from the study site may be a challenge for some of them, especially those in the rural areas. Some of them may have children they cannot leave behind alone when they come for their scheduled visits. Some may have to rely on other caregivers for their travel.
It is important to understand such barriers which may be very different for each study participant. Try to accommodate these barriers as much as possible. It may help to extend the hours the site is open so that participants may not need to take long leaves from work. Some sites can provide an area for child care so that participants can bring their children along. In the least, always try to involve the family and caregivers in conversations about the trial so that they understand why it is important for the participant to be present for each scheduled visit at the site and are cooperative about it.

Barrier #4: Financial difficulties

Many participants may invest their own money for the logistics to participate in clinical trials. If there are delays in the reimbursement process whether due to a prolonged or a slow payment model, the participants may feel unappreciated and start believing the trial is not well organized. This could lead to poor patient retention.
To improve patient compliance and retention, ensure that the payments are prompt. Talk to the participants about their financial difficulties and find out ways how you could help them solve these.
If the research site successfully combats these obstacles, it can ensure more patient recruitment and patient retention and provide positive participant experience. Involving a site management organization (SMO) can facilitate more patient centric services at the site ensuring better patient compliance and retention. The clinical research coordinators (CRCs) of the SMO are attached to specific study sites. While the investigators pay attention to patient care, the CRCs coordinate and conduct patient care visits and assure that all the processes are as per the protocol. They interact closely with the patients and identify barriers to their participation and assist stakeholders in developing strategies for better patient recruitment and patient retention.